Manufacturing Associate (GMP)

4w1 month ago

AmplifyBio

New Albany, US · Full-time · $45,000 – $65,000

About this role

Are you passionate about significantly improving the future of medicine? AmplifyBio is seeking a Manufacturing Associate (GMP) to join the team at our new Manufacturing Enablement Center (AMEC) in New Albany, OH, a facility providing customizable cGMP suites for advanced therapy manufacturing.

In this role, you will execute manufacturing processes within a GMP-compliant facility specializing in cell and gene therapy production. Working under supervision of senior personnel, you will perform tasks related to drug substance and drug product processing, including cell expansion, transfection, purification, formulation, and fill/finish operations.

You will prepare and operate equipment such as bioreactors, centrifuges, chromatography systems, and filtration units while accurately completing manufacturing documentation in accordance with GMP regulations. You will also assist in investigations of deviations, non-conformances, and CAPA activities to support continuous process improvement.

This position offers the chance to be part of an innovation-rich ecosystem designed to advance a diverse range of pharmaceutical products across development stages. You will play an essential role in supporting manufacturing operations and contributing to the advancement of cell and gene therapy products for patient treatment.

Requirements

Experience working in a GMP-compliant manufacturing environment, preferably in cell or gene therapy.
Knowledge of aseptic processing techniques and cleanroom behavior.
Ability to follow detailed standard operating procedures (SOPs) and batch records with precision.
Proficiency with manufacturing equipment including bioreactors, centrifuges, or chromatography systems.
Strong attention to detail for accurate documentation and compliance with regulatory standards.
Ability to work effectively under supervision and collaborate with senior manufacturing personnel.

Responsibilities

Execute manufacturing processes according to established SOPs, batch records, and work instructions for cell and gene therapy products.
Perform tasks related to drug substance and drug product processing including cell expansion, transfection, purification, formulation, and fill/finish operations.
Prepare and operate equipment such as bioreactors, centrifuges, chromatography systems, and filtration units following safety and operational protocols.
Complete manufacturing documentation accurately and in accordance with GMP regulations, including batch records, logbooks, and equipment usage logs.
Participate in the review and revision of manufacturing documents and procedures to ensure compliance with regulatory requirements.
Assist in investigations of deviations, non-conformances, and CAPA activities, contributing to the resolution and prevention of quality incidents.
Perform in-process testing and sampling to monitor critical quality attributes throughout the production process.

Benefits

Opportunity to work at a state-of-the-art Manufacturing Enablement Center (AMEC) with customizable cGMP suites.
Part of an innovation-rich ecosystem designed to advance a diverse range of pharmaceutical products.
Role contributing directly to the advancement of cell and gene therapy products for patient treatment.
Professional development within a growing contract research organization serving the pharmaceutical industry.